FDA Medical devices recall ·
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers recall
- Recall number
- Z-1874-2026
- Date
- (initiated March 3, 2026)
- Company / brand
- Angiodynamics, Inc.
603 Queensbury Ave, Queensbury, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 500 units (100 boxes)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
Why was it recalled?
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); UDI-DI: 25051684006030(Box), 15051684006033(Pouch); Lot No.: A3025039, A3225033;
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1874-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.